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Immune Pharmaceuticals, Inc. Message Board

  • jerrymathers68 jerrymathers68 Mar 18, 2011 4:48 PM Flag

    Wow Bad Karma...

    where is the BOTTOM LESS PIT.....GEEZ ALOT OF VOLUME AND to bring it down late....It really is a POS...i WILL HOLD BUT AM THROUGH With this board and talking about this POS STOCK....NICE REAL NICE

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    • NTERVIEW: Biotech Firm EpiCept Bets Big On New Cancer Drug
      Last update: 3/18/2011 8:23:40 AM

      By Gustav Sandstrom

      STOCKHOLM (Dow Jones)--Swedish-American biotech firm EpiCept Corp. (EPCT) is planning a clinical trial to convince U.S. regulators to approve its cancer treatment Ceplene, hoping for a breakthrough launch which could be vital for the company's future.
      EpiCept, which is headquartered outside New York but has a dual listing on Nasdaq and OMX Stockholm, will next month file its study application to the U.S. Food and Drug Administration and can hopefully start the trial late this year, looking for a launch around 2014, Chief Executive Jack told Dow Jones Newswires.
      "It is crucial that we be successful with Ceplene," Talley said in an interview Thursday. "We have other drugs, but we are a small company and we are not profitable."
      The new trial gives EpiCept a second chance to launch its drug in the world's largest pharmaceutical market after the FDA last summer demanded more proof that Ceplene is efficient enough in prolonging cancer patients' lives.
      There are 12,000-13,000 new leukemia patients in the U.S. each year and around half of them might be treated with Ceplene if the drug is approved, so the commercial potential is substantial, Talley said. U.S. peak sales of the drug could be at least $150 million, he added.
      EpiCept plans to market the drug itself in the U.S., Talley said, adding that it will hire a U.S. sales force of around 30 if the it gets launched.
      "There is a very large upside if we are successful," said Talley. "I think it's highly likely that we will have a successful study," he added.
      Ceplene, which is the world's first treatment to prevent relapses of Acute Myeloid Leukemia, an aggressive blood cancer, is already approved in Europe and marketed in the UK, Germany and Austria by EpiCept's partner, Swedish pharmaceutical company Meda AB (MEDA-A.SK), Talley said.
      The drug, which works by blocking an enzyme which deactivates the white blood cells in the body which destroy the cancer cells, does prolong patients' lives by 1 to 3 years or more, but the upcoming Phase III study will need to be successful enough to convince the FDA, he said.
      If the study fails, EpiCept can still fall back on other drug candidates such as pain treatment NP-1 and on its European Ceplene sales, but the U.S. launch will be a "major factor" for EpiCept's future, said Talley.
      European sales of Ceplene should rise over time, but reimbursement takes a lot of time in that region and the revenue is still too small to be "financially meaningful," Talley said.
      The make-or-break character of the upcoming U.S. trial highlights the biotech industry's inherent riskiness.
      EpiCept's shares in Stockholm lost almost half their value following the FDA's refusal of Ceplene last August, and the outcome of the planned new study may well trigger new drastic moves.
      The FDA will get back to EpiCept a couple of months after the study application is filed in April, but even if it gives clearance to move ahead, the company will need more money to carry out the trial, Chief Financial Officer Robert Cook told Dow Jones Newswires.
      Following a rights issue last month, EpiCept has a cash pool of around $9 million, but its operations require some $1 million a month, which only takes it through most of 2011, he said.
      EpiCept is currently discussing a debt financing agreement with one or more investors, which it hopes to finalize in 2-3 months, Cook said, adding that it is also looking for more drug partnership deals in order to raise more cash.
      By Gustav Sandstrom, Dow Jones Newswires; +46-8-5451-3099;
      (END) Dow Jones Newswires
      March 18, 2011 08:23 ET (12:23 GMT)

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